Sewon Cellontech Selected as Participating Research Institution for Government-Wide R&D Project

[Asia Economy Reporter Hyungsoo Park] Sewon Cellontech announced on the 28th that it will participate as a research institution in the national project for strengthening medical device commercialization capabilities within the ‘2020 1st Pan-Ministerial Full-Cycle Medical Device R&D Project,’ led by Professor Hyunseok Song of the Department of Orthopedics at Catholic University Eunpyeong St. Mary's Hospital.

The Pan-Ministerial Full-Cycle Medical Device R&D Project is a large-scale national research and development (R&D) initiative jointly promoted by the Ministry of Health and Welfare, Ministry of Trade, Industry and Energy, Ministry of Science and ICT, and Ministry of Food and Drug Safety, with a total budget of 1.1971 trillion KRW to be invested by 2025. It integrally supports market-oriented medical device commercialization and the strengthening of the medical device industry's competitiveness.

The proof of safety and efficacy of the bio-collagen patch (Atelocollagen patch) added to arthroscopic rotator cuff repair is a national project clinical study confirming the therapeutic effect of RegenSeal for patients with rotator cuff (shoulder tendon) tears. RegenSeal is a collagen-based tissue supplement independently developed by Sewon Cellontech that implants bio-collagen to supplement defective or damaged soft tissues (ligaments, tendons, muscles, fascia). It received marketing approval from the Ministry of Food and Drug Safety (MFDS) in 2013.

A randomized, single-blind, controlled clinical trial (RCT) will be conducted targeting a test group (30 patients) applying the currently marketed matrix-type RegenSeal together with conventional suturing, and a control group (30 patients) undergoing only conventional suturing. The study will be carried out stepwise over 28 months until December 2022.

Professor Hyunseok Song, the principal investigator at Catholic University Eunpyeong St. Mary's Hospital, previously published a preclinical (animal experiment) research paper in an SCI (Science Citation Index) international journal, demonstrating the enhanced healing ability of RegenSeal in a rabbit rotator cuff tear model in 2017.

Seodongsam Seo, Director of the Regenerative Medical System Innovation Center at Sewon Cellontech, said, "The selection of this national project reflecting medical field demands will establish a foundation to expand the clinical utility of RegenSeal, as well as its market value and practical use, including import substitution and export ripple effects."

This content was produced with the assistance of AI translation services.